MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number A1368-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported device issue was captured as instances of drug inefficacy.Smiths medical received 10 unused kits; however, per request, the product samples were destroyed and smiths medical's quality team was not able to perform an investigation.The anesthetic is a supplied item and the complaint was forwarded to the supplier.Per our supplier's report, batch record review revealed no discrepancies that may have contributed to a complaint of this nature.Results of analytical testing performed on manufacturing retain drug samples met specifications.A review of the kit's device history records, relevant to smiths lot, revealed no deviations or abnormalities related to the reported issue.Based on the information provided, the reported complaints were not confirmed.

Event Description

It was reported that either the bupivacaine or lidocaine contained in the portex® spinal anesthesia tray failed to deliver the appropriate numbness following spinal administration to the patient.Information concerning which of the aforementioned drugs contributed to the incident could not be determined.The patient underwent general anesthesia as a result of the incident.No patient death or serious injury was reported in connection with the incident.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7507943
• MDR Text Key: 108155539
• Report Number: 3012307300-2018-10137
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688037012
• UDI-Public: 20351688037012
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: A1368-25
• Device Lot Number: 3036604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1